Abstract

MONTEAGUDO LICEA, Raiza et al. Validation of an analytical method for quality control and stability study of 10 % Phenylephrine eyedrops. Rev Cubana Farm [online]. 2010, vol.44, n.4, pp.494-502. ISSN 0034-7515.

Phenylephrine is used like mydiatric in eye examinations and other ophthalmic procedures. It is used as vasoconstrictor with local anesthetic agents. In present paper a high ressolution liquid chromatography analytical method was validated to quality control and stability studies of 10 % Phenylephrine (eyedrops). Mathod was based in separation of active principle through a Lichrosorb RO-18 (5 µm) (250 x 4 mm) chromatography column with UV detection at 280 nm using a mobile phase composed by a non-gasified mixture of methanol distilled water (1:1) with 1.1 g of 1-sodium octane-sulphonate by liter adjusted to pH 3,0 with phosphoric acid at a flow speed of 1.0 mL/min. Analytical method was linear, accuracy, specific and exact in the interval of study concentrations.

Keywords : HPLC/method; Phenylephrine; validation.

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